Kornimate/medical-research-clean huggingface dataset:
long term follow up investigation of endobronchial valves in emphysema

Conditions: Pulmonary Emphysema

Summary: this is an observational prospective single arm multicentre study to observe the effect over 5 years of zephyr endobronchial valve therapy for emphysema.

primary objective is pulmonary function as assessed by fev1 and secondary objectives are health related quality of life as assessed by the modified mrc dyspnea score and by the copd assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in germany. patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. the study will observe normal clinical practice. no investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. zephyr endobronchial valve has ce mark and is fully reimbursed in germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.

Eligibility criteria:
inclusion criteria: * patients of both genders of at least 18 years of age * understand and voluntarily sign an informed consent form. * fev1 \> 15% predicted and \< 45% predicted * rv \>180% predicted * diagnosis of emphysema with ct evidence of hyperinflation . absence of collateral ventilation according to chartis assessment system exclusion criteria: • active pulmonary infection

Keywords: valves endobronchial endoscopic lung volume reduction pulmonx zephyr chartis emphysema copd
cancer and mild cognitive impairment a patient-caregiver behavioral intervention

Conditions: Cancer; Cognitive Impairment

Summary: the purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. the investigator will loan participants a tablet computer (ipad) to use for videoconferencing and train the participant in its use. participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. for most people, it will take upwards of 2 - 4 months to complete this study.


Eligibility criteria:
inclusion criteria: patient inclusion criteria include: 1. patients with stage i-iv breast, colon, rectal, or lung cancer (newly diagnosed within 6 months; age 65 or older. 2. participants must be living at home (either in her/his own home). 3. participants must be fluent in english and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. 4. exhibit mild cognitive impairment. 5. have an informal family caregiver. inclusion criteria: (partner or family member) inclusion criteria include: 1. caregivers are 18 older. 2. be fluent in english and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions. 3. either co-reside with the patient or spend at least 3-4 hours day caregiving. 4. not exhibit cognitive impairment. exclusion criteria for both patients and caregivers: 1. participant has visual or hearing impairments that preclude participation. 2. participant has dementia and do not have the capacity to participate. 3. have a serious untreated psychiatric illness as documented in medical chart review. 4. the patient and the caregiver score less than a 3 on the national comprehensive cancer network (nccn) distress thermometer (dt) on a scale 0 to 10 to screen for distress.

Keywords: aging behavioral intervention mental health communication
the effect of somatosensory perceptıon and proprıoceptıon on upper extremıty functıonal skılls

Conditions: Cerebral Palsy; Somatosensory Disorders; Upper Extremity Dysfunction; Proprioceptive Disorders

Summary: cerebral palsy (cp) is a non-progressive neurodevelopmental disorder characterized by posture and movement disorders as a result of damage to the immature brain for any reason before, during or after birth.in addition to tone, postural and neuromuscular control in children with cerebral palsy; problems are also observed in communication skills, perceptual and cognitive systems and sensory systems.

in neurodevelopmental theory, sensory and motor systems mutually support the development of each other. in addition to the motor problems observed in sp; sensory-motor impairment, which occurs with the effects of systems such as proprioception, tactile (touch), and vestibular (balance), emerges as the main problem. with the involvement of the central nervous system (cns) in cp, the sensory systems are also affected along with the motor systems. the involvement of the sensory system is seen in 45% of these children and presents with a white matter lesion. one of the important factors affecting the activities of daily living (adl) in children with cerebral palsy is the deficiencies in their functions as a result of the affected upper extremity. deficiencies in sensory input can cause delays in learning new motor movements. this can result in disuse of the extremities and sensitivity. the somatosensory cortex, which is important for sensory integration; it is the area of the brain that is sensitive to tactile sensations from the body. it is known that the somatosensory system, which carries these tactile stimuli to the somatosensory cortex, is active from the early stage of life. sensory and motor interactions experienced in the early stages of life are important for motor development even in the early stages. the improvement in measurable cortical responses of the tactile system; it starts from the 8th week of intrauterine and continues until the postpartum period. in the newborn period, the infant's responses to tactile and proprioceptive stimuli play an important role in the development of motor, cognitive, social and communication skills during infancy and early childhood. the aim of this study is to investigate the effects of somatosensory perception and proprioception on upper extremity functional skills in children with hemiparetic and diparetic cp.

Eligibility criteria:
inclusion criteria: * diagnosed with hemiparetic and diparetic cp with gross motor function classification system (gmfcs) level ≤ 3 * children with ≤ 2 upper extremity muscles according to the modified ashworth scale (mas) * children with manual skills classification system (macs) ≤ 3 * not being diagnosed with mental disability by the ram (guidance research center) * children with cp aged 6-18 years * not receiving surgery or botox (botulinum toxin) treatment in the last 6 months * children with cp with parental approval exclusion criteria: * joint contracture in the shoulder, elbow and hand-wrist * having any hearing or vision problems
mobile-based games for cognitive training in children with neurodevelopmental disorders

Conditions: Autism Spectrum Disorder

Summary: autism spectrum disorder (asd) is a neurodevelopmental disorder with characteristic deficits in social functioning and presence of stereotypic behavior. several research studies have examined potential deficits in cognitive skills, such as working memory, in this condition. a meta-analysis of the studies aimed at evaluating working memory (wm) in autistic population suggested deficits in visual and verbal aspects of wm. working memory training has also been studied in other neurodevelopmental disorders such as attention deficit hyperactivity disorder (adhd). the study includes development of mobile-based games for training wm and other cognitive skills in patients and the evaluation of such training in reducing symptoms of asd. these games may also be useful for other neurodevelopmental disorders.


Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder or another related neurodevelopmental disorder with symptoms of asd exclusion criteria: * inability to use smartphones/tablets * serious intellectual disabilities. * sensory impairment

Keywords: digital intervention serious games
etoposide in the first-line treatment of adult ebv-hlh

Conditions: Hemophagocytic Lymphohistiocytosis

Summary: his study aimed to investigate the efficacy of etoposide as the first line therapy for adult epstein-barr virus-associated hemophagocytic lymphohistiocytosis.


Eligibility criteria:
inclusion criteria: 1. patients were older than 18 years of age 2. diagnosed as ebv-hemophagocytic lymphohistiocytosis (hlh) 3. patients did not receive any treatment for hlh before 4. informed consent exclusion criteria: 1. heart function above grade ii (nyha) 2. accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2 3. pregnancy or lactating women 4. allergic to pegaspargase, doxorubicin or etoposide 5. active bleeding of the internal organs 6. uncontrollable infection 7. history of acute and chronic pancreatitis 8. participate in other clinical research at the same time
efficacy of budesonide-formoterol in bronchiectasis

Conditions: Bronchiectasis

Summary: some studies have concluded that high-dose inhaled steroids (is) are effective in the clinical control of patients with bronchiectasis, however the high doses needed provokes some adverse effects and lower doses are not effective. combined treatment with budesonide and formoterol have demostrated to be effective in patients with asthma and copd achieving the reduction of steroid dose thanks to the adition of a long-acting beta 2 agonists. there are no studies in the literature analysing the effect of combined treatment in patients with bronchiectasis. the objective of this study is to compare the efficacy and safety of formoterol-medium dose of budesonide in a single inhaler versus high-dose of budesonide in the clinical control of patientes with non-cystic fibrosis bronchiectasis. study design: randomized (3 months) parallel groups study. patients: patients with bronchiectasis diagnosed by high-resolution ct scan and chronic obstructive airway obstruction. exclusion: asthma and current or past smokers. methods: run in period in all patients with high dose of budesonide (1600 mcg/day) for 3 months. after that, randomization into two groups: 1. the same treatment (1600 mcg/day of budesonide) or combined treatment with lower dose of budesonide (18 mcg/day of formoterol and 800 mcg of budesonide) in a single turbuhaler inhaler during 3 months. studied variables: clinical, functional, quality of life, microbiological and number of side effects.


Eligibility criteria:
inclusion criteria: * 18-80 years old patients diagnosed of non-cystic fibrosis bronchiectasis * more than 1 pulmonary lobe affected * chronic obstructive airflow obstruction * stable phase of the disease exclusion criteria: * asthma, copd or current/past smnokers * no consent * known intolerance to budesonide or formoterol

Keywords: budesonide formoterol non cystic fibrosis bronchiectasis
phase 3 study to evaluate the efficacy and safety of dw-1030 and eperisone hcl in acute back pain patients

Conditions: Acute Back Pain

Summary: the purpose of this clinical study is to determine whether or not dw-1030 is not inferior to eperisone hcl in efficacy and safety.


Eligibility criteria:
inclusion criteria: * adult males/females aged over 18 years * patients with symptom of acute skeletomuscle myospasm and back pain * patients with pain vas value over 40 mm in visit 2 * subjects who voluntarily or legal guardian agreed with written consent exclusion criteria: * patients with back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection * muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis * patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point * patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point * patients with severe gi tract disorder, heart disease, hypertension * patients who had taken nsaids within 24hours from the screening point
diacerein as adjuvant to diclofenac sodium in indian patients of osteoarthritis (oa) knee

Conditions: Osteoarthritis; Osteoarthritis, Knee

Summary: the purpose of this study is to evaluate clinical effectiveness of diacerein as add on therapy to diclofenac sodium in indian patients of osteoarthritis (oa) knee.

currently symptomatic relief is provided by the use of nonsteroidal anti-inflammatory drugs (nsaids) but they do not reverse the basic pathology of disease, rather may accelerate it, like degeneration of cartilage, inhibition of chondroitin synthesis and suppression of proteoglycans synthesis by the chondrocyte. research shows that il-1β plays a fundamental role in osteoarthritis pathophysiology and cartilage destruction. diacerein, a purified compound with anthraquinonic structure, inhibits il-1β, retarding all pathological processes initiated in oa. also, diacerein has proven analgesic efficacy comparable to that of diclofenac in patients of osteoarthritis knee12. because of these factors, the present study has been planned to evaluate the clinical effectiveness of diacerein as add on therapy to diclofenac sodium in indian patients of symptomatic oa knee.

Eligibility criteria:
inclusion criteria: * primary osteoarthritis patients recruited were between 35 to 60 years of age, with x-ray confirmed kellgren-lawrence grade13 ii or iii severity primary tibiofemoral oa, according to the american college of rheumatology criteria. * women of childbearing age had to provide evidence of adequate contraception prior to inclusion. exclusion criteria: those patients were excluded from the present study who: * were of age less than 35 years or more than 60 years * presented with active concomitant gastroduodenal disorders, hepatic and renal impairment within last 30 days prior to receiving the study drug * were diagnosed to have any inflammatory arthritis, gout or acute trauma of the knee, hip or spine; accompanying oa of the hip of sufficient severity to interfere with the functional assessment of the knee * had previous or ongoing treatment with oral sysdoa (e.g., glucosamine sulphate, chondroitin sulphate, diacerein, piascledine), anti-depressants, tranquillisers, antacids or antibiotics; were having active cardiac lesion or hypertension, were pregnant females and those who were planning their pregnancy during the study * were having a known hypersensitivity to diclofenac sodium, to diacerein, to similar compounds, to the excipients or paracetamol, have history of painful knee conditions other than oa * have persistent diarrhoea or laxative use; severe gastrointestinal disorders, severe obesity, severe parenchymal organ disease, or anaemia (haemoglobin\< 10.0 g/ dl or haematocrit \< 30%). * patients who received oral, intramuscular, intraarticular or soft tissue injections of corticosteroids within last eight weeks before receiving the first dose of the study medication, or had undergone joint lavage and arthroscopic procedures in the previous 6 months, were also excluded.

Keywords: oa knee
extension study of pimavanserin in irritability associated with autism spectrum disorder

Conditions: Irritability Associated With Autism Spectrum Disorder

Summary: 52-week, open-label extension study of double-blind study acp-103-069 to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with asd in children and adolescents (aged 5 to 17 years). acp-103-069 is a 6-week, randomized, double-blind, fixed-dose, placebo controlled, parallel group study of pimavanserin in children and adolescents with irritability associated with autism spectrum disorder (asd).

this study will be conducted as a 52-week, open-label extension study of the antecedent double-blind study to determine the long-term safety and tolerability of pimavanserin for the treatment of irritability associated with asd in children and adolescents (5 through 17 years old at the time of enrolling into the antecedent double-blind study).

Eligibility criteria:
inclusion criteria: * has completed the treatment period of study acp-103-069 * informed consent prior to the conduct of any study procedures * continues to be both clinically stable and not at imminent risk of suicide or injury to self, others, or property * continues to be medically stable at enrollment * for female patients only: unable to become pregnant or agree to use a highly effective non-hormonal method of contraception. females of childbearing potential must have a negative pregnancy test exclusion criteria: * patient or parent/legally accepted representative is judged by the investigator to be inappropriate for the study * requires treatment with a medication prohibited by the protocol, including concomitant psychotropic drugs targeting irritability, including those used off-label (clonidine, guanfacine, and propranolol; lithium, valproate), medications that prolong the qt interval; and strong cytochrome p450 (cyp) 3a4 enzyme (cyp3a4) inhibitors and inducers * at a significant risk of suicide, or is a danger to self or others * at risk of significant violent behavior to the extent that participation would pose an undue risk to other patients, caregivers, or others * positive urine drug test * serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies * any change in medical or treatment status that may increase the risk associated with taking pimavanserin, would interfere with safety assessments, or would confound the interpretation of study results * clinically significant abnormal ecg of protocol-defined cardiac conduction abnormalities * weight \<15 kg * additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.
observational prospective study of immune checkpoint inhibitors for solid neoplasms

Conditions: Cancer

Summary: this prospective, multicenter observational study included all patients with solid neoplasms who received treatment with immune checkpoint inhibitors (icis) in clinical practice, regardless of tumor type, tumor stage, type of immunotherapy, or treatment lines. this study aimed to assess the use, effectiveness, and safety of icis for solid neoplasms in real-world populations, which can provide insights into clinical decisions associated with the use of icis for the treatment of cancer patients in the real-world setting.


Eligibility criteria:
inclusion criteria: * age at least 18 years. * pathologically confirmed diagnosis of a solid tumor cancer. * patients receiving treatment with immune checkpoint inhibitors. * ability to understand and willingness to provide the informed consent. exclusion criteria: * age \< 18 years. * patients with hematological malignancies or solid benign tumors. * mental disorders, drug abuse, and social condition that may negatively impact compliance in the opinion of the investigator.
phase i study evaluating the safety and pharmacokinetics of budesonide, glycopyrronium, and formoterol fumarate inhalation aerosol (bgf mdi) in healthy volunteers

Conditions: Healthy Volunteers

Summary: this is a phase i, randomized, double-blind within device, single-dose, four-period, six-treatment, cross-over study evaluating the safety and pharmacokinetics of three doses of budesonide, glycopyrronium, and formoterol fumarate inhalation aerosol (bgf mdi), one dose of glycopyrronium and formoterol fumarate inhalation aerosol (gff mdi), and two doses of symbicort® inhalation aerosol in healthy volunteers. the primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in bgf mdi provides comparable systemic exposure \[pharmacokinetics (pk)\] to budesonide following administration of symbicort mdi.


Eligibility criteria:
inclusion criteria: * provide signed written informed consent form * 18 and 45 years (inclusive) * healthy subject confirmed by a thorough medical history and physical examination, ecg, vital signs and clinical laboratory tests * females of childbearing potential and males with female partners of childbearing potential must agree to use medically acceptable contraception * body mass index (bmi) between 18.5 and 32 kg/m2 (inclusive) and a minimum weight of 50 kg at the screening visit * results of complete laboratory analyses should be within the normal range or determined to be not clinically significant by the investigator exclusion criteria: * pregnancy, nursing female subjects, or subjects trying to conceive * clinically significant medical conditions * history of ecg abnormalities * symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention * known diagnosis of glaucoma * known or suspected history of substance-related disorders within 1 year of screening * treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period * hypersensitivity to lactose or any drug or component of the formulation(s) used in this study * positive screen for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag) or positive hepatitis c antibody at screening. * major surgery within four weeks or minor surgery within 2 weeks of drug administration * any other condition and/or situation that causes the investigator to deem a subject unsuitable for study participation